Firstly, I was surprised that the EDDC clinical operations team was so small. I had assumed that since EDDC is such a huge body, they would have more hands involved in the clinical trials given the number of projects they must be working on. But of course it was explained to me that they mostly outsource the work to a Contract Research Organisation (CRO) to manage the trials, and EDDC role was more of a Sponsor, or the overseeing organisation and also the one that conducts audits to ensure standards are met. Another important role that I learnt about was that EDDC was in charge of the Investigator’s Booklet (IB), an incredibly important document that helps to guide the doctors and nurses involved in human trials. I can imagine that different hospitals in Singapore might do certain procedures differently, all the more in a different country like the US where other trial sites may be.
Secondly, the importance of safety was a pertinent point made by the speaker. Safety is everyone’s role and good practices are not just for one group, but for every group involved in drug development. One bad inspection can mean the end of years of work, and that must be devastating not just for the team but for the number of people the drug could have possibly helped. An interesting thought I had was about how they implement phamacovigilance, which is the safety practice around adverse events that may happen during the trials. It is hard to imagine how they try to teach everyone involved a standard set of procedures for an unimaginable number of possible scenarios.
JAN ANNE 